Click here for full Prescribing Information, including Instructions for Use, for SPIRIVA HANDIHALER (tiotropium bromide inhalation powder).
IMPORTANT SAFETY INFORMATION
SPIRIVA® HANDIHALER® (tiotropium bromide inhalation powder) is contraindicated in patients with a history of hypersensitivity to tiotropium, ipratropium, or any component of this product. Immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported.
SPIRIVA HANDIHALER is intended as a once-daily maintenance treatment for COPD, and should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm.
Immediate hypersensitivity reactions, including urticaria, angioedema (swelling of lips, tongue, or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA. If such a reaction occurs, discontinue SPIRIVA HANDIHALER at once and consider alternative treatments. Given the similar structural formula of atropine to tiotropium, patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to SPIRIVA HANDIHALER.
SPIRIVA HANDIHALER should be used with caution in patients with severe hypersensitivity to milk proteins.
Inhaled medicines, including SPIRIVA HANDIHALER may cause paradoxical bronchospasm. If this occurs, it should be treated with an inhaled short-acting beta2-agonist, such as albuterol. Treatment with SPIRIVA HANDIHALER should be stopped and other treatments considered.
SPIRIVA HANDIHALER should be used with caution in patients with narrow-angle glaucoma. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately should any of these signs or symptoms develop.
Since dizziness and blurred vision may occur with the use of SPIRIVA HANDIHALER, caution patients about engaging in activities such as driving a vehicle, or operating appliances or machinery.
SPIRIVA HANDIHALER should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a physician immediately should any of these signs or symptoms develop.
Patients with moderate to severe renal impairment (creatinine clearance of < 60 mL/min) treated with SPIRIVA HANDIHALER should be monitored closely for anticholinergic side effects.
The most common adverse reactions >5% incidence and exceeded placebo by ≥ 1% with SPIRIVA HANDIHALER (placebo) in COPD trials were upper respiratory tract infection 41% (37%), dry mouth 16% (3%), sinusitis 11% (9%), pharyngitis 9% (7%), non-specific chest pain 7% (5%), urinary tract infection 7% (5%), dyspepsia 6% (5%), and rhinitis 6% (5%). In addition, the most common reported adverse reactions ≥ 3% incidence and higher than placebo from the 4-year trial with SPIRIVA HANDIHALER (placebo) not included above were headache 5.7% (4.5%), depression 4.4% (3.3%), insomnia 4.4% (3.0%), and arthralgia 4.2% (3.1%).
SPIRIVA HANDIHALER may interact additively with concomitantly used anticholinergic medications. Avoid coadministration with other anticholinergic-containing drugs.
SPIRIVA capsules should not be swallowed and should only be inhaled through the mouth (oral inhalation) using the HANDIHALER device, and the HANDIHALER device should not be used for administering other medications.
SPIRIVA HANDIHALER is indicated for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for reducing COPD exacerbations.
CL-SV-0002 HANDIHALER Professional ISI